Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S029 · decided 2019-09-19
Approval details
- PMA number
- P130028
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Algovita Spinal Cord Stimulation System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2019-08-28
- Decision date
- 2019-09-19
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Implementation of an additional bonding step to the manufacturing process of the printed circuit board assembly to provide reinforcement to the interface between the micro USB connector and the circuit board.
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